Thrombo-Prophylaxis Prevents Thrombotic Events in Home-Managed Covid Patients a Registry Study

2020 ◽  
Vol 5 (4) ◽  

This pilot registry analyzes data from subjects with COVID-19 infection and mild symptoms, followed and treated at home. Antithrombotic prophylaxis was used in all subjects. A comparison was made with comparable cases that had not used prophylaxis. A control group (36 subjects) without prophylaxis was compared to a prophylaxis group (67 subjects using LMWH and 35 using defibrotide). At two weeks, there were no DVTs or thrombotic disease in the prophylaxis groups. Also, the evolution of the main respiratory symptoms was significantly better in the prophylaxis groups (p<0.05). No patients went to ITU: 4 out of 36 patients in the comparative group went briefly to hospitals. In subjects, using LMWH 1 went to hospital as in the defibrotide group. None was put in ventilation. D-dimer values were fluctuating and not usable to define the presence of a thrombotic condition. This aspect is under further evaluation. No significant side effects were observed. Conclusions: Antithrombotic prophylaxis should be started as soon as possible (home patients) and used during all the high-risk conditions. The importance of venous thromboembolism in medical patients with severe respiratory disease (as COVID), even in the early phases, has been stressed and it is well known; it cannot be considered a new observation and requires adequate, immediate prophylaxis.

2016 ◽  
Vol 115 (06) ◽  
pp. 1240-1248 ◽  
Author(s):  
Alex Spyropoulos ◽  
Julie Zrubek ◽  
Walter Ageno ◽  
Gregory Albers ◽  
C. Elliott ◽  
...  

SummaryHospital-associated venous thromboembolism (VTE) is a leading cause of premature death and disability worldwide. Evidence-based guidelines recommend that anticoagulant thromboprophylaxis be given to hospitalised medical patients at risk of VTE, but suggest against routine use of thromboprophylaxis beyond the hospital stay. The MARINER study is a randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of thromboprophylaxis using rivaroxaban, begun at hospital discharge and continued for 45 days, for preventing symptomatic VTE in high-risk medical patients. Eligible patients are identified using the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE VTE) risk score, combined with a laboratory test, D-dimer. The rivaroxaban regimen is 10 mg once daily for patients with CrCl ≥ 50 ml/min, or 7.5 mg once daily for patients with CrCl ≥ 30 ml/min and < 50 ml/ min. The primary efficacy outcome is the composite of symptomatic VTE (lower extremity deep-vein thrombosis and non-fatal pulmonary embolism) and VTE-related death. The principal safety outcome is major bleeding. A blinded clinical events committee adjudicates all suspected outcome events. The sample size is event-driven with an estimated total of 8,000 patients to acquire 161 primary outcome events. Study design features that distinguish MARINER from previous and ongoing thromboprophylaxis trials in medically ill patients are: (i) use of a validated risk assessment model (IMPROVE VTE) and D-dimer determination for identifying eligible patients at high risk of VTE, (ii) randomisation at the time of hospital discharge, (iii) a 45-day treatment period and (iv) restriction of the primary efficacy outcome to symptomatic VTE events.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 16-17
Author(s):  
Desiree Campoy ◽  
Katia Flores ◽  
Gonzalo Artaza ◽  
César A Velasquez ◽  
Tania Canals ◽  
...  

BACKGROUND After a standard anticoagulation period (3-6 months), the risk of venous thromboembolism recurrence (RVTER) needs to be considered. Such risk is higher in unprovoked events and patients with persistent risk factor. The increase of D-dimer (DD) levels during the therapy seems to be strongly associated to RVTER. The use of rivaroxaban 10 mg/day and apixaban 2.5mg/12h as an extended therapy (ET) after the standard anticoagulation period has been proven to be an effective strategy to prevent recurrence without increasing bleeding events. AIM To assess the effectiveness and safety of reduced doses of rivaroxaban and apixaban as ET in patients with RVTER and to compare their DD levels with those of a control group on anticoagulant therapy at a standard dose. METHODS From April 2016 to June 2020, we included patients with venous thromboembolism (VTE) who received ET with rivaroxaban and apixaban with/at reduced doses. Dose reduction was performed following the clinical algorithm of our unit (Fig. 1). The DD values were determined using HemosIl D-Dimer HS-500 and the cut-off value was established at 500 µg/L DD levels were compared with a control group of 235 patients with VTE who received ET with standard doses of anticoagulation. DD levels were measured at the time of diagnosis (D1), initiation of treatment (D2) and 3 months after treatment (D3). RESULTS From a total of 116 patients (65.5% women), 77.6% (n=90) received rivaroxaban 10 mg/24h and 22.4% received apixaban 2.5 mg/12h as an ET. The mean duration of the initial anticoagulant therapy was 12 +/- 8.8 months. The mean DD value prior to the ET was 388 µg/L. In this group, 63.8% (n=74) was an unprovoked VTE and 17.2% (20) had hereditary thrombophilia. The mean of follow-up time was 6.9 +/- 8.3 months. No recurrences of VTE were observed during the follow-up and only one major bleeding event was reported in a high-bleeding risk patient. We observed a progressive decrease of DD levels from the VTE diagnosis to the last visit, with D1, D2, and D3 values of 987 µg/L ± 324, 388 µg/L ± 134, and 288 µg/L ± 98, respectively. There were no differences in d-dimer concentrations between patients with reduce doses of rivaroxaban or apixaban and the control group with standard doses (D1: 85.6% vs 81%, p =0.22; D2: 10.2% vs 8.0%, p =0.14; and D3: 9.1% vs 9.5%, p =0.18). CONCLUSIONS Our data indicated that an ET strategy with reduced doses of rivaroxaban or apixaban is effective and safe. We did not observe significant differences in DD levels at follow-up compared to the control group receiving a standard dose of anticoagulation. Further studies are needed in order to select and standardize dose reduction criteria in secondary prevention. Figure 1 Disclosures Campoy: boehringer ingelheim: Consultancy; Daiichi Sankyo: Speakers Bureau. Sierra:Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Jazz Pharmaceuticals: Research Funding; Astellas: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead-Kite: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Daiichi Sankyo: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Olivera:Daiichi Sankyo: Consultancy, Speakers Bureau; Pfizer: Consultancy, Speakers Bureau; Boehringer Ingelheim: Consultancy, Speakers Bureau; BAYER: Consultancy.


2009 ◽  
Vol 101 (05) ◽  
pp. 893-901 ◽  
Author(s):  
Mauro Campanini ◽  
Mauro Silingardi ◽  
Gianluigi Scannapieco ◽  
Antonino Mazzone ◽  
Giovanna Magni ◽  
...  

SummaryHospitalised medical patients are at increased risk of venous thromboembolism (VTE), but the incidence of hospitalisation-related VTE in unselected medical inpatients has not been extensively studied, and uncertainties remain about the optimal use of thromboprophylaxis in this setting. Aims of our prospective, observational study were to assess the prevalence of VTE and the incidence of symptomatic, hospitalisation-related events in a cohort of consecutive patients admitted to 27 Internal Medicine Departments, and to evaluate clinical factors associated with the use of thromboprophylaxis. Between March and September 2006, a total of 4,846 patients were included in the study. Symptomatic VTE with onset of symptoms later than 48 hours after admission (”hospital-acquired” events, primary study end-point) occurred in 26 patients (0.55٪), while the overall prevalence of VTE (including diagnosis prior to or at admission) was 3.65٪. During hospital stay antithrombotic prophylaxis was administered in 41.6٪ of patients, and in 58.7% of those for whom prophylaxis was recommended according to the 2004 Guidelines of the American College of Chest Physicians. The choice of administering thromboprophylaxis or not appeared qualitatively adherent to indications from randomised clinical trials and international guidelines, and bed rest was the strongest determinant of the use of prophylaxis. Data from our real-world study confirm that VTE is a relevant complication in patients admitted to Internal Medicine Departments, and recommended tromboprophylaxis is still under-used, in particular in some patients groups. Further efforts are needed to better define risk profile and to optimise prophylaxis in the heterogeneous setting of medical inpatients.


TH Open ◽  
2020 ◽  
Vol 04 (01) ◽  
pp. e59-e65 ◽  
Author(s):  
Alex C. Spyropoulos ◽  
Concetta Lipardi ◽  
Jianfeng Xu ◽  
Colleen Peluso ◽  
Theodore E. Spiro ◽  
...  

AbstractAn individualized approach to identify acutely ill medical patients at increased risk of venous thromboembolism (VTE) and a low risk of bleeding to optimize the benefit and risk of extended thromboprophylaxis (ET) is needed. The International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) VTE risk score has undergone extensive external validation in medically ill patients for in-hospital use and a modified model was used in the MARINER trial of ET also incorporating an elevated D-dimer. The MAGELLAN study demonstrated efficacy with rivaroxaban but had excess bleeding. This retrospective analysis investigated whether the modified IMPROVE VTE model with an elevated D-dimer could identify a high VTE risk subgroup of patients for ET from a subpopulation of the MAGELLAN study, which was previously identified as having a lower risk of bleeding. We incorporated the modified IMPROVE VTE score using a cutoff score of 4 or more or 2 and 3 with an elevated D-dimer (>2 times the upper limit of normal) to the MAGELLAN subpopulation. In total, 56% of the patients met the high-risk criteria. In the placebo group, the total VTE event rate at Day 35 was 7.94% in the high-risk group and 2.83% for patients in the lower-risk group. A reduction in VTE was observed with rivaroxaban in the high-risk group (relative risk [RR]: 0.68, 95% confidence interval [CI]: 0.51–0.91, p = 0.008) and in the lower-risk group (RR: 0.69, 95% CI: 0.40 -1.20, p = 0.187). The modified IMPROVE VTE score with an elevated D-dimer identified a nearly threefold higher VTE risk subpopulation of patients where a significant benefit exists for ET using rivaroxaban.


2014 ◽  
Vol 111 (03) ◽  
pp. 531-538 ◽  
Author(s):  
Drahomir Aujesky ◽  
Daniel Hayoz ◽  
Jürg Beer ◽  
Marc Husmann ◽  
Beat Frauchiger ◽  
...  

SummaryThere is a need to validate risk assessment tools for hospitalised medical patients at risk of venous thromboembolism (VTE). We investigated whether a predefined cut-off of the Geneva Risk Score, as compared to the Padua Prediction Score, accurately distinguishes low-risk from high-risk patients regardless of the use of thromboprophylaxis. In the multicentre, prospective Explicit ASsessment of Thromboembolic RIsk and Prophylaxis for Medical PATients in SwitzErland (ESTIMATE) cohort study, 1,478 hospitalised medical patients were enrolled of whom 637 (43%) did not receive thromboprophylaxis. The primary endpoint was symptomatic VTE or VTE-related death at 90 days. The study is registered at ClinicalTrials.gov, number NCT01277536. According to the Geneva Risk Score, the cumulative rate of the primary endpoint was 3.2% (95% confidence interval [CI] 2.2–4.6%) in 962 high-risk vs 0.6% (95% CI 0.2–1.9%) in 516 low-risk patients (p=0.002); among patients without prophylaxis, this rate was 3.5% vs 0.8% (p=0.029), respectively. In comparison, the Padua Prediction Score yielded a cumulative rate of the primary endpoint of 3.5% (95% CI 2.3–5.3%) in 714 high-risk vs 1.1% (95% CI 0.6–2.3%) in 764 lowrisk patients (p=0.002); among patients without prophylaxis, this rate was 3.2% vs 1.5% (p=0.130), respectively. Negative likelihood ratio was 0.28 (95% CI 0.10–0.83) for the Geneva Risk Score and 0.51 (95% CI 0.28–0.93) for the Padua Prediction Score. In conclusion, among hospitalised medical patients, the Geneva Risk Score predicted VTE and VTE-related mortality and compared favourably with the Padua Prediction Score, particularly for its accuracy to identify low-risk patients who do not require thromboprophylaxis.


2015 ◽  
Vol 113 (05) ◽  
pp. 1127-1134 ◽  
Author(s):  
David Spirk ◽  
Mathieu Nendaz ◽  
Drahomir Aujesky ◽  
Daniel Hayoz ◽  
Jürg H. Beer ◽  
...  

summaryBoth, underuse and overuse of thromboprophylaxis in hospitalised medical patients is common. We aimed to explore clinical factors associated with the use of pharmacological or mechanical thromboprophylaxis in acutely ill medical patients at high (Geneva Risk Score ≥ 3 points) vs low (Geneva Risk Score < 3 points) risk of venous thromboembolism. Overall, 1,478 hospitalised medical patients from eight large Swiss hospitals were enrolled in the prospective Explicit ASsessment of Thromboembolic RIsk and Prophylaxis for Medical PATients in SwitzErland (ESTIMATE) cohort study. The study is registered on ClinicalTrials. gov, number NCT01277536. Thromboprophylaxis increased stepwise with increasing Geneva Risk Score (p< 0.001). Among the 962 high-risk patients, 366 (38 %) received no thromboprophylaxis; cancer-associated thrombocytopenia (OR 4.78, 95 % CI 2.75–8.31, p< 0.001), active bleeding on admission (OR 2.88, 95 % CI 1.69–4.92, p< 0.001), and thrombocytopenia without cancer (OR 2.54, 95 % CI 1.31–4.95, p=0.006) were independently associated with the absence of prophylaxis. The use of thromboprophylaxis declined with increasing severity of thrombocytopenia (p=0.001). Among the 516 low-risk patients, 245 (48 %) received thromboprophylaxis; none of the investigated clinical factors predicted its use. In conclusion, in acutely ill medical patients, bleeding and thrombocytopenia were the most important factors for the absence of thromboprophylaxis among highrisk patients. The use of thromboprophylaxis among low-risk patients was inconsistent, without clearly identifiable predictors, and should be addressed in further research.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3678-3678
Author(s):  
Anat Gafter-Gvili ◽  
Genady Drozdinsky ◽  
Oren Zusman ◽  
Shiri Kushnir ◽  
Leonard Leibovici

Background and Aims Venous thromboembolism (VTE) is considered as a preventable cause of death for hospitalized patients. Current guidelines recommend pharmacologic prophylaxis for medical patients considered high risk for VTE, despite failure of studies to show reduction in mortality. We aimed to assess the benefit and safety of VTE prophylaxis in acutely ill medical patients hospitalized in internal medicine wards. Methods Retrospective cohort study of all patients admitted to the internal medicine and acute geriatric departments, with an admission lasting more than 48 hours, during 2012-2018. Patients who received pharmacologic prophylaxis were compared to those who did not. The primary outcome was 30-day mortality. Secondary outcomes were the 90 day incidence of pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), and major bleeding. Propensity-weighted logistic multivariable analysis was performed. Results A total of 18890 patient-unique episodes were included in the analysis. Of them 3206 (17%) received prophylaxis. A total of 1309 (6.9%) died. 540/1309 (41.3%) of those who received VTE prophylaxis died and 769/1309 (58.7%) of those who did not receive prophylaxis died. VTE Prophylaxis was not associated with a reduction in mortality, multivariate-adjusted OR 0.99 (95% CI 0.84-1.14). One hundred and forty two patients (0.7%) developed VTE. The frequency of VTE among patients who received VTE prophylaxis was 31% (44/142) compared with 69% (98/142) in patients who did not receive prophylaxis. The frequency of VTE in patients who had a Padua score ≥4 and received VTE prophylaxis, was 1.9% (30/1573) compared with 1.6% (44/2797) in those with a Padua score ≥4 who did not receive prophylaxis. 74/142 (52.1%) of patients with VTE had a Padua score ≥4, 44/1309 (1.4%) of those who received VTE prophylaxis and 98/15864 (0.6%) of those who did not. VTE Prophylaxis was not associated with reduction in VTE in the whole cohort, multivariable-adjusted OR 1.09 (95% CI 0.52-2.29). VTE prophylaxis was associated with an increase in major bleeding (multivariable-adjusted OR 1.24, 95% CI 1.04-1.48) Conclusion The current practice of routinely administering VTE prophylaxis to medically ill patients considered at high risk for VTE, resulted in a high risk for bleeding a without clear clinical benefit, and should be reassessed. Disclosures No relevant conflicts of interest to declare.


Author(s):  
Aleksandar Đenić

COVID-19 patients have a high risk of thrombosis of the arterial and venous systems due to extensive systemic inflammation, platelet activation, endothelial dysfunction, and stasis. D-dimer is an important prognostic marker of mortality caused by COVID-19 patients and its increased values indicate tissue damage and inflammation. The incidence of venous thromboembolism (VTe) is between 16 and 49% as a complication of more severe forms of COVID-19 infection in patients hospitalized in intensive care units. Prophylactic doses of low molecular weight heparin (lMWH) should be given to all hospitalized patients with COVID-19 infection in the absence of active bleeding. The safest way is to adjust the low molecular weight heparin (lMWH) dose according to body weight, especially in obese patients. Unfractionated heparin (UFH) is used in patients with a creatinine clearance of less than 30 ml/min. The therapeutic dose of anticoagulation should be discontinued if the platelet count is <50 × 109 /l or fibrinogen <1.0 g/l. Clinically significant bleeding events are higher in those who received therapeutic doses compared to those with standard thromboprophylaxis doses. Thrombolytic therapy is recommended in patients with proven pulmonary embolism (Pe) and hemodynamic instability or signs of cardiogenic shock, who are not at high risk of bleeding. In hospitalized COVID-19 patients with a high clinical risk of developing venous thromboembolism (VTe) and D-dimer values greater than 2600 ng/ml, the use of therapeutic doses of lMWH in doses adjusted to the patient's body weight should be considered, in the absence of a higher risk of bleeding.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4218-4218 ◽  
Author(s):  
Charles Edward Mahan ◽  
Yang Liu ◽  
James D. Douketis ◽  
Alexander G.G. Turpie ◽  
Undaleeb Dairkee ◽  
...  

Abstract Abstract 4218 Introduction. Venous Thromboembolism (VTE) remains the most common cause of preventable death in hospitalized patients despite more than 25 guidelines and over 5 decades of data on VTE prevention. American College of Chest Physicians (ACCP) and International Union of Angiology (IUA) guideline recommendations are primarily based off of risk factors utilized for entry into randomized controlled trials (RCT) or post-hoc analysis of these RCTs. These guidelines recommend a group-based, as opposed to an individualized risk assessment, approach. It is currently unknown how these risk factors interact in a quantitative manner. There are currently no weighted, validated, VTE risk assessment models (RAM) that are data-derived in medical patients. A retrospective VTE RAM (IMPACT ILL) was recently derived from the multinational IMPROVE registry in hospitalized medical patients. (Table 1) The “VTE-VALOURR ” is a retrospective, multi-center, case control, validation study of this RAM. The VTE-VALOURR is also assessing other VTE and bleeding risk factors. Methods. ICD-10 reports and the McMaster Transfusion Registry for Utilization Surveillance and Tracking (TRUST) database, which contains demographics, transfusion data, and approximately 50 clinical variables including thrombotic outcomes of inpatients, were used as the data source at 3 hospitals. Inclusion criteria were hospitalized medical patients ≥ 18 years with ≥ 3 days length of stay (LOS). Exclusion criteria were patients with pregnancy, mental health disorders, atrial fibrillation/ flutter, trauma, spinal cord injury, surgery within 90 days, VTE within 24 hours of admission, treatment dose anticoagulants (including warfarin) within 48 hours of admission, or transferred from a non-McMaster acute care facility. Lower extremity deep vein thrombosis (DVT) and pulmonary embolism out to 90 days post admission were the thrombotic outcomes of interest and verified by chart review. Upper extremity DVT was excluded. Descriptive statistics (proportions and frequencies) were used to summarize binary variables. Results. From January 1st, 2005 to February 28th, 2011, 247,241 hospitalizations occurred at 3 McMaster hospitals. After exclusionary criteria were applied, 779 VTE events were identified. (Figure 1) Of these, 419 were excluded because they were VTE events not related to a previous hospitalization (i.e. community-acquired). Of the remaining 360 patients, 240 have been reviewed with 93 confirmed, included, VTE events having occurred, 147 events being further excluded, and another 120 patients still requiring review. We present an interim analysis of the 93 currently included patients. Of the included patients, 68 (73%) received some form of prophylaxis during their hospital stay while 35 (38%) received appropriate type, dose and duration of prophylaxis. Fifty-eight (62%) of VTE events were therefore “preventable.” Number of risk factors per patient and risk scores for the 93 patients are listed in tables 2 and 3. Conclusions. Validation of this VTE RAM will identify medical patients at risk of VTE that do not readily fit into group-specific VTE risk categories. Additionally, validation will identify subsets of patients at especially high risk of VTE and focus future randomized controlled trials. Other VTE risk factors may be identified with the study. Review of the 120 VTE cohort patients needs to be completed as well as review of a comparator control cohort. Approximately 80% of the current VTE cohort appears to have a score of 2 or above and be at moderate to high risk of VTE. Final results of approximately 150 VTE patients will be presented along with the control cohort as well as if the model is valid. Disclosures: Turpie: Astellas Pharma Europe: Consultancy; Bayer HealthCare AG: Consultancy; Portola Pharma: Consultancy; sanofi-aventis: Consultancy.


2011 ◽  
Vol 106 (12) ◽  
pp. 1103-1108 ◽  
Author(s):  
Noppacharn Uaprasert ◽  
Laddawan Vajragupta ◽  
Numphung Numkarunarunrote ◽  
Nathaporn Tanpowpong ◽  
Pranee Sutcharitchan ◽  
...  

SummaryThromboprophylaxis for venous thromboembolism (VTE) failed to reduce overall mortality in hospitalised medical patients. As a VTE prediction model for Asians is still lacking, this study aimed to identify very high risk patients who would be the main target for prevention. In 2009, medical patients admitted to King Chulalongkorn Memorial hospital, a tertiary care centre, were prospectively evaluated for risk factors. The high-risk cohort was monitored for symptomatic VTE until six weeks after discharge. No heparin prophylaxis was given. Of 1,290 high-risk patients, 27 (2.1%, 95% confidence interval [CI] 1.3–2.9) developed proven VTE, 25.9% of which were diagnosed after discharge. Cases with VTE stayed longer in the hospital (median 18 vs. 11 days, p < 0.001). The significant risk factors in a multivariate analysis were autoimmune disease, solid tumours, family history of VTE, varicose vein and oestrogen with the relative risks of 11.8, 4.7, 120.3, 40.1 and 17.1 (p < 0.001, 0.001, 0.001, 0.002 and 0.038), respectively. Either autoimmune disease or solid tumours were found in 63% of VTE with the relative risk of 4.5 (95% CI 2.1–9.7, p < 0.001). In contrast, previously reported VTE scores in western patients could not stratify the VTE risks, but all the scores predicted higher mortality. In conclusion, VTE is common in Asian hospitalised medical patients. Patients with autoimmune disease and those with solid tumours are highly susceptible to VTE. A prophylactic strategy in these groups is required.


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